Ignite Creation Date:
2025-12-24 @ 10:49 PM
Ignite Modification Date:
2025-12-25 @ 8:18 PM
Study NCT ID:
NCT03767569
Status:
UNKNOWN
Last Update Posted:
2018-12-06
First Post:
2018-04-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007247', 'term': 'Infertility, Female'}], 'ancestors': [{'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D007246', 'term': 'Infertility'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007294', 'term': 'Inositol'}, {'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 134}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-03', 'completionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-12-05', 'studyFirstSubmitDate': '2018-04-06', 'studyFirstSubmitQcDate': '2018-12-05', 'lastUpdatePostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Serum testosterone level after 12 weeks of administration of Myo-Inositol', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'Androstenedione and SHBG (Sex Hormone Binding Globulin) plasma levels after 12 weeks of administration of Myo-Inositol', 'timeFrame': '2 years'}, {'measure': 'Number of mature oocytes', 'timeFrame': '2 years'}, {'measure': 'Embryo quality', 'timeFrame': '2 years', 'description': "Day 3 embryos will be classified as transferable or cryopreservable/ 'good-quality embryos' (GQE) according to the criteria described by Van Landuyt et al. (2013). Blastocysts will be categorized according to Gardner et al. (1998) and Gardner and Schoolcraft (1999)."}, {'measure': 'Implantation rate (%)', 'timeFrame': '2 years'}, {'measure': 'Clinical pregnancy rate (%)', 'timeFrame': '2 years'}, {'measure': 'Live birth rate in fresh cycle', 'timeFrame': '2 years'}, {'measure': 'Cumulative live birth rate after 1 cycle', 'timeFrame': '2 years'}, {'measure': 'Ovarian Hyperstimulation Syndrome rate', 'timeFrame': '2 years'}, {'measure': 'Consumption of gonadotrophins', 'timeFrame': '2 years', 'description': 'measurement in IU'}, {'measure': 'Stimulation days', 'timeFrame': '2 years', 'description': 'measurement in days'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PCOS', 'Female Infertility']}, 'descriptionModule': {'briefSummary': 'A randomized controlled trial to evaluate whether pretreatment with myo-inositol can lower testosterone levels and improve clinical outcomes in hyperandrogenic PCOS patients undergoing ART'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 18-40 years\n* PCOS phenotypes A, B and C\n* Signed informed consent\n\nExclusion Criteria:\n\n* Other relevant endocrine disorders\n* Contraindications to the use of gonadotropins\n* Endometriosis grade 3-4\n* BMI \\> 35'}, 'identificationModule': {'nctId': 'NCT03767569', 'briefTitle': 'Myo-inositol as Pretreatment in Hyperandrogenic PCOS Patients', 'organization': {'class': 'OTHER', 'fullName': 'Universitair Ziekenhuis Brussel'}, 'officialTitle': 'Pretreatment With Myo-inositol in Hyperandrogenic PCOS Patients Undergoing ART: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Gynositol.2018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myo-inositol', 'description': 'Pretreatment with Gynositol (Myo-Inositol 4mg + Folic Acid 0.4mg) daily during 12 weeks before start of ART (Assisted Reproductive Technology)', 'interventionNames': ['Drug: Myo-inositol']}, {'type': 'OTHER', 'label': 'Folic acid', 'description': 'Folic acid 0.4 mg daily during 12 weeks before start of ART', 'interventionNames': ['Drug: Folic Acid']}], 'interventions': [{'name': 'Myo-inositol', 'type': 'DRUG', 'description': 'Myo-inositol and Folic acid daily', 'armGroupLabels': ['Myo-inositol']}, {'name': 'Folic Acid', 'type': 'DRUG', 'description': 'Folic Acid daily', 'armGroupLabels': ['Folic acid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Brussels', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Michel De Vos, PhD', 'role': 'CONTACT', 'email': 'michel.devos@uzbrussel.be', 'phone': '+3224776699'}, {'name': 'Sylvie De Rijdt, MD', 'role': 'CONTACT', 'email': 'sylvie.derijdt@uzbrussel.be'}], 'facility': 'Universitair Ziekenhuis Brussel', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}], 'centralContacts': [{'name': 'Michel De Vos, PhD', 'role': 'CONTACT', 'email': 'michel.devos@uzbrussel.be', 'phone': '+3224776699'}, {'name': 'Sylvie De Rijdt, MD', 'role': 'CONTACT', 'email': 'sylvie.derijdt@uzbrussel.be'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitair Ziekenhuis Brussel', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}